DQS offers various services in the field of approval of medical devices and certification of management systems in healthcare.

MDSAP- Medical Device Single Audit Program

The Medical Device Single Audit Program (MDSAP) offers the opportunity to demonstrate compliance with the regulatory requirements of up to five participating countries through a certification process: Australia, Brazil, Japan, Canada and the USA. The advantages of the program are not only the recognition of the results in the registration of medical devices but also the reduction of on-site inspections by the participating authorities.

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Introduction to the Medical Device Single Audit Program MDSAP

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How to access the Japanese market with medical devices (for overseas companies)

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Change of certifier and/or notified body

Health care certifications

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MED unannounced audits

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Change of certifier and/or notified body

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CE marking: Notes on handling unannounced audits

Primary packaging materials for medicinal products

ISO 15378

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Change of certifier and/or notified body

CE marking

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MED unannounced audits

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Change of certifier and/or notified body

Blog
interview-join-dqs-eine geschaeftsfrau macht sich notizen
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CE marking: Notes on handling unannounced audits

ISO 13485

ISO 13485:2016 defines the requirements for a quality management system to demonstrate an organization's ability to provide medical devices and related services that consistently meet the requirements of both customers and applicable regulatory provisions.